PainPhase 4NCT02570841
Pain Thresholds Under High-dose Topical Capsaicin
A Phase 4 study testing Topical High dose Capsaicin in people with Pain, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Aim of the study is to determine heat pain thresholds (HPT in °C) and cold pain thresholds (CPT in °C) during topical capsaicin 8% application, and mechanical pain thresholds (MPT in g) immediately after to find out the exact skin temperature by which capsaicin initiates the application pain (heat pain threshold, HPT… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Topical High dose Capsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2015to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers 18 ore more years old
Who cannot join
- dermatologic or neurologic injuries on both thighs, (possible) pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesia, Critical Care and Pain Medicine
Vienna, State of Vienna, 1090
About this study
Official title: Heat-, Cold-, and Mechanical Pain Thresholds Under Exposition of High Dose Topical Capsaicin
Aim of the study is to determine heat pain thresholds (HPT in °C) and cold pain thresholds (CPT in °C) during topical capsaicin 8% application, and mechanical pain thresholds (MPT in g) immediately after to find out the exact skin temperature by which capsaicin initiates the application pain (heat pain threshold, HPT in °C) but also the temperature by which capsaicin does not yet trigger a cold pain (cold pain threshold, CPT in °C). Moreover the investigators want to find out the mechanical pain threshold in g from topical capsaicin and to verify a prolonged effect of capsaicin on the pain thresholds.
Read the detailed description
Capsaicin is the main pungent ingredient in chili peppers. Topical capsaicin 8% is used for the treatment of peripheral neuropathic pain. Application of capsaicin 8% provokes distinct pain by activating the transient receptor potential vanilloid 1 (TRPV1) receptor. Cooling the skin results in a reliable prevention of the application pain. However, the necessary cooling temperature and if cooling itself produces application pain, is unknown.
Materials and Methods: 10 female and 10 male healthy volunteers will be enrolled in a randomised, double blind, placebo controlled, cross-over study. The left or right forearm of each subject is going to be treated with a capsaicin 8% patch (QUTENZA, Astellas Pharma, Tokyo, Japan) of 9 cm² or a placebo patch (Demo patch, Astellas Pharma, Tokyo, Japan) of the same size for 60 min. Then the other forearm (which has not been tested before) will be treated with the remaining patch. During capsaicin and placebo exposure HPT in °C and CPT in °C are going to be obtained by the thermode of a thermal sensory analyser, TSA-II (Medoc Ltd., Ramat Yishai, Israel). Temperature increase/decrease of the thermode will be stopped, as soon as the subject presses a switch because of a beginning pain sensation. Immediately after exposure a pin prick test will be performed 5 times in a row by pressing a Mini-Spike (B. Braun Melsungen AG, Melsungen, Germany) slowly against the skin of the application areal to determine the pressure necessary to provoke a sharp pain (Mechanical pain threshold in g). 2 weeks later HPT, CPT, and MPT will be determined again in the areas of capsaicin and placebo exhibition.
- Conditions
- Pain
- Being tested
- Topical High dose Capsaicin, Topical Placebo
- Keywords
- Heat pain threshold, Cold pain threshold, Mechanical pain threshold, High dose Capsaicin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical High dose CapsaicinDrug
Also called Topical Capsaicin 8%, Qutenza® patch
Topical High dose Capsaicin exposure within an area of 3x3 cm for 60 minutes
Topical PlaceboDrug
Also called Demo patch
Placebo exposure within an area of 3x3 cm for 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Active comparator | Treatment with Topical High dose Capsaicin Receives: Drug: Topical High dose Capsaicin |
| Placebo | Placebo comparator | Treatment with Topical Placebo Receives: Drug: Topical Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat pain threshold (HPT) in degrees Celsius (°C)
During capsaicin and placebo exposure HPT in degrees Celsius (°C) is determined by a thermal sensory analyser TSA-II (Medoc Ltd.)
Measured: 60 minutes during topical highdose Capsaicin/Placebo exposure
Secondary outcomes (5)
Cold pain threshold (CPT) in degrees Celsius (°C)
During capsaicin and placebo exposure CPT in degrees Celsius (°C) is determined by a thermal sensory analyser TSA-II (Medoc Ltd.)
Measured: 60 minutes during topical highdose Capsaicin/Placebo exposure
Mechanical pain threshold (MPT) in grams (g)
After capsaicin and placebo exposure MPT in grams (g) is determined by pressing a Mini-Spike (B. Braun Melsungen AG, Melsungen, Germany) slowly against the skin of the application areal to determine the pressure necessary to provoke a sharp pain
Measured: Immediately after topical highdose Capsaicin/Placebo exposure
HPT in degrees Celsius (°C)
HPT in degrees Celsius (°C) will be determined again in the areas of capsaicin and placebo Exhibition
Measured: 2 weeks after exposure
CPT in degrees Celsius (°C)
CPT in degrees Celsius (°C) will be determined again in the areas of capsaicin and placebo Exhibition
Measured: 2 weeks after exposure
MPT in grams (g)
MPT in grams (g) will be determined again in the areas of capsaicin and placebo Exhibition
Measured: 2 weeks after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma GmbH
- Responsible party
- Principal investigator, E. Knolle, MD, Medical University of Vienna
- Investigators
- Erich Knolle, MD, Principal investigator, Department of Anesthesia, Critical Care and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570841
- Sponsor's protocol ID
- FA738B0401
- Status last verified
- Oct 2015
- First submitted
- 8 Sep 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat-, Cold-, and Mechanical Pain Thresholds Under Exposition of High Dose Topical Capsaicin
- ClinicalTrials.gov ID
- NCT02570841
- Acronym / sponsor ID
- FA738B0401
- Conditions
- Pain
- Keywords
- Heat pain threshold, Cold pain threshold, Mechanical pain threshold, High dose Capsaicin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Astellas Pharma GmbH
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to determine heat pain thresholds (HPT in °C) and cold pain thresholds (CPT in °C) during topical capsaicin 8% application, and mechanical pain thresholds (MPT in g) immediately after to find out the exact skin temperature by which capsaicin initiates the application pain (heat pain threshold, HPT in °C) but also the temperature by which capsaicin does not yet trigger a cold pain (cold pain threshold, CPT in °C). Moreover the investigators want to find out the mechanical pain threshold in g from topical capsaicin and to verify a prolonged effect of capsaicin on the pain thresholds.
Detailed description
Capsaicin is the main pungent ingredient in chili peppers. Topical capsaicin 8% is used for the treatment of peripheral neuropathic pain. Application of capsaicin 8% provokes distinct pain by activating the transient receptor potential vanilloid 1 (TRPV1) receptor. Cooling the skin results in a reliable prevention of the application pain. However, the necessary cooling temperature and if cooling itself produces application pain, is unknown.
Materials and Methods: 10 female and 10 male healthy volunteers will be enrolled in a randomised, double blind, placebo controlled, cross-over study. The left or right forearm of each subject is going to be treated with a capsaicin 8% patch (QUTENZA, Astellas Pharma, Tokyo, Japan) of 9 cm² or a placebo patch (Demo patch, Astellas Pharma, Tokyo, Japan) of the same size for 60 min. Then the other forearm (which has not been tested before) will be treated with the remaining patch. During capsaicin and placebo exposure HPT in °C and CPT in °C are going to be obtained by the thermode of a thermal sensory analyser, TSA-II (Medoc Ltd., Ramat Yishai, Israel). Temperature increase/decrease of the thermode will be stopped, as soon as the subject presses a switch because of a beginning pain sensation. Immediately after exposure a pin prick test will be performed 5 times in a row by pressing a Mini-Spike (B. Braun Melsungen AG, Melsungen, Germany) slowly against the skin of the application areal to determine the pressure necessary to provoke a sharp pain (Mechanical pain threshold in g). 2 weeks later HPT, CPT, and MPT will be determined again in the areas of capsaicin and placebo exhibition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Active comparator | Drug: Topical High dose CapsaicinTreatment with Topical High dose Capsaicin |
| Placebo | Placebo comparator | Drug: Topical PlaceboTreatment with Topical Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers 18 ore more years old
Key exclusion criteria (1 listed)
- dermatologic or neurologic injuries on both thighs, (possible) pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical High dose CapsaicinAlso: Topical Capsaicin 8%, Qutenza® patchTopical High dose Capsaicin exposure within an area of 3x3 cm for 60 minutes | Drug | Capsaicin |
| Topical PlaceboAlso: Demo patchPlacebo exposure within an area of 3x3 cm for 60 minutes | Drug | Placebo |
Primary outcome
Heat pain threshold (HPT) in degrees Celsius (°C)
Time frame: 60 minutes during topical highdose Capsaicin/Placebo exposure
During capsaicin and placebo exposure HPT in degrees Celsius (°C) is determined by a thermal sensory analyser TSA-II (Medoc Ltd.)
5 secondary outcomes
Cold pain threshold (CPT) in degrees Celsius (°C)
Time frame: 60 minutes during topical highdose Capsaicin/Placebo exposure
Mechanical pain threshold (MPT) in grams (g)
Time frame: Immediately after topical highdose Capsaicin/Placebo exposure
HPT in degrees Celsius (°C)
Time frame: 2 weeks after exposure
CPT in degrees Celsius (°C)
Time frame: 2 weeks after exposure
MPT in grams (g)
Time frame: 2 weeks after exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erich Knolle, MD principal investigator
Department of Anesthesia, Critical Care and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical High dose Capsaicin in people with Pain, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heat pain threshold (HPT) in degrees Celsius (°C) (time frame: 60 minutes during topical highdose Capsaicin/Placebo exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.